GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261418Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00733132622474), received between Aug 10, 2018 and Apr 30, 2026 — classified as 1 death, 32 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE AAA24-01 TAMBE POST APPROVAL STUDY AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA CLINICAL DATABASE. ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE IV THORACOABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH A CONTAINED RUPTURE OF THE PERIVISCERAL ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN REINTERVENED ON (B)(6) 2026, ENDOVASCULAR REPAIR OF THE LEFT COMMON ILIAC ARTERY ANEURYSM WITH A LEFT ILIAC EXTENSION INTO THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT HYPOGASTRIC ARTERY WAS COIL EMBOLIZED. THERE WAS AN AORTIC CUFF IMPLANTED AT THE DISTAL TO TAMBE AT THE JUNCTION WITH THE EXCLUDER BIFURCATING DEVICE TO OVERLAP THIS REGION TO PREVENT A POSSIBLE JUNCTIONAL ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY ON (B)(6) 2026 PATIENT DEVELOPED ACUTE KIDNEY FAILURE, THE EVENT IS ONGOING.

  Patient problems: Clinical Endoleak

  MAUDE report 25048557 ↗
• InjuryAug 22, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2025, THIS 74-YEAR-OLD FEMALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED PROCEDURE FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG ENDOPROSTHESIS AND TWO GORE® EXCLUDER® ENDOPROSTHESIS CONTRALATERAL LEG ENDOPROSTHESIS DEVICES. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. THE SITES WERE ACCESSED PERCUTANEOUSLY. THERE WERE NO ADDITIONAL CORRECTIVE PROCEDURES DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. HE WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT A CTA IN WHICH THE PATIENT HAD AN UNEXPECTED RESULT. THE IMAGE WAS READ AS HAVING A DEVICE DEFICIENCY; THE PROXIMAL STENT ROW COVERS APPROXIMATELY HALF OF THE LOWEST RENAL ARTERY OSTIUM. (LEFT RENAL ARTERY). THERE IS NO LOSS OF PATENCY OF A GORE DEVICE NOTED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22880043 ↗
• InjuryJun 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT261418 AND PLC141400). ON (B)(6) 2022, PATIENT UNDERWENT AN REINTERVENTION SURGERY TO TREAT A TYPE II ENDOLEAK. ON (B)(6) 2025, A CT REVEALED A RECURRENT TYPE II ENDOLEAK. ON (B)(6) 2025, PATIENT UNDERWENT A TRANSCAVAL EMBOLIZATION DUE TO THIS RECURRENT TYPE II ENDOLEAK. DURING REINTERVENTION SURGERY, A TYPE 1B ENDOLEAK WAS ALSO NOTED IN THE RIGHT ILIAC LIMB. ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION SURGERY TO TREAT THE TYPE 1B ENDOLEAK, IN WHICH A PLC DEVICE WAS IMPLANTED TO EXTEND THE RIGHT ILIAC. IT WAS ALSO REPORTED THE TYPE1B ENDOLEAK WAS RESOLVED, AND THE TYPE II ENDOLEAK REMAINED. PHYSICIAN WILL CONTINUE TO MONITOR THIS TYPE II ENDOLEAK. FSA WAS NOTIFIED OF PREVIOUS REINTERVENTIONS ((B)(6) 2022 AND (B)(6) 2025) ON (B)(6) 2025, AND DOES NOT HAVE ANY FURTHER INFORMATION, AS HE WAS NOT PRESENT. THE CAUSE OF THE PERSISTENT TYPE II ENDOEAK AS PER PHYSICIAN, IS DUE TO PATIENT FACTORS, WITH NO SPECIFIC CAUSE.

  Patient problems: Clinical Endoleak

  MAUDE report 22134263 ↗
• InjuryJan 15, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2015, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024, A TYPE 1B ENDOLEAK WAS DETECTED ON THE IPSILATERAL LIMB. ON (B)(6) 2024, A REINTERVENTION OCCURRED, WITH AN ADDITIONAL GRAFT IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21159335 ↗
• MalfunctionJun 3, 2024Device Handling Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3, CONTRALATERAL LEG AND ILIAC EXTENDER), GORE® DRYSEAL FLEX INTRODUCER SHEATH (12FR AND 16FR) AND GORE® MOLDING & OCCLUSION BALLOON CATHETER. REPORTEDLY, THE PHYSICIAN FIRST USED A 12FR SHEATH INADVERTENTLY, ONCE REALIZED, PHYSICIAN REMOVED THE SHEATH AND INSPECTED THE DEVICE (GRAFT) HAD NO DAMAGE AND PROCEEDED TO USE THE 16FR SHEATH. NO ISSUE WAS NOTED WITH THE 16FR SHEATH UNTIL THE FIRST DEPLOYMENT OF THE DEVICE WAS COMPLETED AND THE CONTRALATERAL GATE WAS CANNULATED AND PHYSICIAN CONFIRMED USING A MOB BALLOON PER PHYSICIAN TECHNIQUE, IT WAS AT THIS POINT, NOTED THAT THE SHEATH VALVE WAS LEAKING AND IT WAS NOT HOLDING THE SALINE AND BLOOD COMING BUT NO IMPACT TO PATIENT. THEY CONTINUED TO COMPLETE THE DEPLOYMENT OF THE STENT GRAFT. WHEN PHYSICIAN WAS REMOVING THE CONSTRAINING KNOB (TRANSPARENT) RESISTANCE WAS FELT. PHYSICIAN STOPPED AND CHECKED UNDER FLUORO AND NOTICED THE TOP OF THE DEVICE WAS CONSTRAINING AS SHE WAS TRYING TO REMOVE THE TRANSPARENT KNOB. PHYSICIAN ADVANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446813 ↗
• InjuryMay 15, 2024Material Invagination; Patient-Device Incompatibility; Material Deformation; Material Invagination; Patient-Device Incompatibility; Material Deformation

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED TOGETHER WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT ON THE LEFT SIDE AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (EXTENDED DEEP IN THE LEFT INTERNAL ILIAC ARTERY (LIIA)) ON (B)(6) 2024 TO TREAT A PATIENT WITH AN ANEURYSM IN THE LEFT COMMON ILIAC ARTERY (LCIA). THE PATIENT ALSO HAD A DISSECTION IN THE LCIA, THE PROXIMAL LIIA WAS DILATED, AS WELL AS THROMBUS IN HIS INFRARENAL NECK. THE IMPLANT PROCEDURE WENT WELL, FINAL ANGIOGRAPHY SHOWED GREAT RESULT. ABOUT ONE MONTH LATER ON (B)(6) 2024, THE PATIENT RETURNED TO THE HOSPITAL WITH NO BLOOD SUPPLY TOWARD THE LEGS. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT261418) INFOLDED COMPLETELY AND WAS BLOCKING THE BLOOD SUPPLY TOWARDS THE LEGS. THEY CONVERTED THE PATIENT AND EXPLANTED THE DEVICES. PATIENT IS DOING WELL NOW.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19318797 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS (CIAA). THE AAA WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESES (RLT261418/(B)(6). COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) THIS DATE DETERMINED THE AAA MAXIMUM DIAMETER MEASURED 68MM, THE LEFT COMMON ILIAC ARTERY ANEURYSM (LCIAA) MAXIMUM DIAMETER MEASURED 60MM; AND THE RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIAA) MAXIMUM DIAMETER MEASURED 45MM. THE LCIAA WAS TREATED WITH A PXC141400/14007774 AND A PXC141200/ (B)(6) WITH EMBOLIZATION OF THE LIIA. THE RCIAA, THE IPSILATERAL SIDE WAS EXTENDED WITH A PXC141200/13972402 WITH COIL EMBOLIZATION OF RIIA. THE PATIENT IS REPORTED TO HAVE A MAXIMUM INFRARENAL NECK ANGLE OF 75 DEGREES, A PROXIMAL LANDING ZONE DIAMETER RANGING 23-19MM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. ON OCTOBER 19, 2015, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REPORTS THE MAXIMUM DIAMETER OF THE AAA MEASURED 63MM, THE MAXIMUM DIAMETER OF THE LCIAA MEASURED 41MM AND THE MAXIMUM DIAMETER OF THE RCIAA MEASURED 53MM. ON OCTOBER 6, 2023, FOLLOW-UP CTA REPORTS THE MAXIMUM DIAME

  Patient problems: Rupture

  MAUDE report 19188231 ↗
• InjuryMar 27, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE TREATMENT PLAN INCLUDED PLACEMENT OF AN 18CM TRUNK-IPSILATERAL LEG COMPONENT. IT WAS NOTED THAT AN ANGIOGRAPHY RUN TO VERIFY LENGTHS WAS NOT PERFORMED PRIOR TO DEVICE PLACEMENT. AFTER IMPLANTATION OF THE TRUNK-IPSILATERAL LEG COMPONENT, IT WAS OBSERVED THAT THE DEVICE WAS TOO LONG AND INADVERTENTLY COVERED THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY. THE RIGHT INTERNAL ILIAC ARTERY WAS COILED AND COVERED. THE LEFT INTERNAL ILIAC ARTERY WAS PRESERVED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18984725 ↗
• InjuryDec 22, 2023Restricted Flow rate; Obstruction of Flow; Patient-Device Incompatibility; Restricted Flow rate; Obstruction of Flow; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR ZONE 10- COMMON ILIAC UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS ((B)(6) ON THE LEFT SIDE AND A (B)(6) ON THE RIGHT SIDE) TO TREAT AN ANEURYSM. THE FINAL ANGIO RUN SHOWED THAT EVERYTHING LOOKED FINE WITH DEPLOYMENT AND PROCEDURE WAS SUCCESSFUL. THERE WAS NO DEVICE COMPRESSION OR KINKING ON THE DEVICE THAT MAY HAVE CAUSED THE LEFT LIMB OF THE TRUNK IPSILATERAL LEG TO THROMBOSED. ON (B)(6), 2023, THE PATIENT UNDERWENT A REINTERVENTION IN ZONE 10- COMMON ILIAC REVISION TO PRIOR EVAR PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (B)(6). FIELD SALES ASSOCIATE (FSA) WAS INFORMED ON (B)(6) ABOUT THE PROCEDURE THAT THE PATIENT CAME TO EMERGENCY ROOM (ER) WITH DIMINISHED FLOW OF LEFT LIMB OF THE MAIN BODY GRAFT ((B)(6) AS THE LIMB HAD THROMBOSED. THERE WERE NO ISSUES WITH THE RIGHT SIDE LIMB (B)(6)THE MEDICAL TEAM USED AN ANGIOJET TO REMOVE THE CLOT FROM THE LIMB AND AT THAT TIME THE FSA ARRIVED. THE THROMBOSED LIMB HAD CLEAR ACCESS OF FLOW WITH THE CLOT CLEARED AND THEN THEY REALIGNED THE LEFT LIMB OF THE TRUNK IPSILATERAL LEG WITH A (B)(6). PATIENT IS DOING OKAY AFTER THE PROCEDURE AND

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18387184 ↗
• InjuryNov 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, THE PATIENT HAD AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT261418 & PXC141400). DURING FOLLOW UP IMAGING ON (B)(6) 2022, REVEALED A TYPE 1A ENDOLEAK WITH THE SAC MEASURED 7 CM ON NON-CON CT. DURING FOLLOW UP CTA ON (B)(6) 2023, THE SAC MEASURED 7.9 CM. THEN ANOTHER CTA DONE ON (B)(6) 2023 THE SAC MEASURED 8.2 CM X 7.5 CM. ON (B)(6) 2023, THE PATIENT WAS BROUGHT IN FOR A REINTERVENTION ENDOVASCULAR PROCEDURE IN ZONE 9 INFRARENAL, IN WHICH THE PHYSICIAN EXTENDED PROXIMALLY BY ADDING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER CONFORMABLE -CXA260005) DEVICE FOLLOWED BY APTUS ENDO ANCHORING. THIS DID NOT RESOLVE THE ENDOLEAK AS SHOWN IN ANGIOGRAM. THE PROCEDURE WAS WELL-TOLERATED AND WITHOUT COMPLICATION. THE PHYSICIAN WILL CONTINUE TO MONITOR THINGS FOR NOW.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18067665 ↗
• InjuryJun 14, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2023, THE PHYSICIAN INFORMED THE GORE REPRESENTATIVE THAT AN INTERVENTION WOULD BE PERFORMED TO TREAT A PROXIMAL TYPE I ENDOLEAK AND A POSSIBLE DISTAL TYPE I ENDOLEAK (INDETERMINATE ENDOLEAK WAS OBSERVED). IT WAS ALSO REPORTED THAT THE ANEURYSM HAD GROWN BY AN ESTIMATED 1.5CM. ON (B)(6) 2023, THE REINTERVENTION WAS ATTEMPTED. HOWEVER, IT WAS REPORTED THAT ACCESS WAS UNATTAINABLE AS THE ACCESS VESSEL WAS OF POOR QUALITY. THEREFORE, THE SURGEON ELECTED TO ABORT THE CASE. NO REINTERVENTION WAS PERFORMED AND, DUE TO THE PATIENT¿S DNR STATUS AND THE CONDITION OF THE ACCESS VESSELS, THERE ARE NO PLANS FOR ANOTHER REINTERVENTION ATTEMPT.

  Patient problems: Aneurysm expansion

  MAUDE report 17131810 ↗
• InjuryMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2016 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 58MM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3 DEPLOYMENT SYSTEM. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED AND DETERMINED THE MAXIMUM AORTIC DIAMETER MEASURED 59MM. ON (B)(6) 2023, A FOLLOW-UP ULTRASOUND WAS PERFORMED AND DETERMINED THE MAXIMUM AORTIC DIAMETER MEASURED 90.8MM. ON (B)(6) 2023, A TYPE II ENDOLEAK WAS IDENTIFIED AND PERCUTANEOUS TRANSCAVAL COIL EMBOLIZATION OF THE ENDOLEAK WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. IT IS UNKNOWN IF THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm expansion

  MAUDE report 16854501 ↗
• InjuryFeb 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT A PLANNED REINTERVENTION UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (AORTIC EXTENDER) TO TREAT A TYPE 2 ENDOLEAK BY EXTENDING PROXIMALLY. THE PATIENT PREVIOUSLY HAD AN EVAR PROCEDURE WITH A RIGHT SIDED IBE DONE. THE EVAR WAS INTACT, AND THE IBE WAS STILL PATENT. REPORTEDLY, THE CTA (IMAGES AVAILABLE) DEMONSTRATED A TYPE 2 ENDOLEAK FROM WHAT THE DOCTOR DIAGNOSED AS A PATENT IMA VESSEL. ADDITIONALLY, THE PHYSICIAN OPTIONED TO EXTEND PROXIMALLY WITH AN AORTIC CUFF (AORTIC EXTENDER) EVEN THOUGH THERE WAS NO EVIDENCE OF A TYPE 1A ENDOLEAK (AS TWO RADIOLOGISTS READ THE CTA SCAN AS A TYPE 1A ENDOLEAK) AS PER STATEMENT OF THE PHYSICIAN. PHYSICIAN IMPLANTED THE AORTIC CUFF, NONETHELESS. THE PATIENT TOLERATED THE PROCEDURE. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: THERE APPEARS TO BE CONTRAST IN THE PORTAL VEIN. THIS IS SUPPOSED TO BE ARTERIAL PHASE, BUT IT SEEMS MORE LIKE THE DELAYED PHASE. THIS BOLUS/TIMING ISSUE IMPACTS THE ABILITY TO FULLY EVALUATE THE DIFFERENCE BETWEEN A TYPE 1 VS TYPE 2 ENDOLEAK. THERE APPEARS TO BE CONSIDERABLE CONTRAST WITHIN THE ARTERIAL PHAS

  Patient problems: Clinical Endoleak

  MAUDE report 16375393 ↗
• InjuryDec 30, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATENT TOLERATED THE PROCEDURE ON (B)(6) 2022, THE PATIENT UNDERWENT FOLLOW-UP ANGIOGRAM WHICH SHOWED PATENT LUMBAR ARTERIES AT THE LEVEL OF THE PROXIMAL NECK THAT APPEARED TO BE THE SOURCE. APTUS SCREWS WERE PLACED IN THE ORIGINAL EXCLUDER® MAIN BODY AND THEN A EXCLUDER® AORTIC EXTENDER COMPONENT WAS IMPLANTED AND EXTENDED COVERAGE APROXIMATLY 5MM PROXIMALLY. FINAL ANGIOGRAMS CONTINUE TO SHOW A SMALL ENDOLEAK THAT IS FELT TO BE TYPE 2 DUE TO THE LUMBAR ARTERIES. THERE IS NO TYPE 1A ENDOLEAK AND IT IS FELT THERE NEVER WAS.

  Patient problems: Aneurysm

  MAUDE report 16080973 ↗
• InjurySep 16, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED TO GORE THAT A KINK AND NARROWING OF THE IPSILATERAL LEG OF A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS OBSERVED THROUGH THE FINAL ANGIOGRAPHY DURING THE IMPLANT ON (B)(6) 2021. THE SAME KINK AND NARROWING WAS ALSO OBSERVED DURING THE ONE MONTH FOLLOW-UP BUT WAS NOT SEEN AS AN ISSUE. ON THE ONE YEAR CT CONTROL THE PHYSICIAN DECIDED TO REINFORCE THE STENT GRAFT IN THE NARROW PART WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXA115901E) IN THE NEAR FUTURE. THE PATIENT REMAINS SYMPTOM FREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437483 ↗
• InjuryApr 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON (B)(6) 2017. THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK ON MARCH 16, 2022. THE PATIENT WAS TREATED FOR ENDOLEAK WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM (CXA280005E ¿ LOT: 23550552) ON (B)(6) 2022. AFTER TWO DILATATIONS, NO TYPE I ENDOLEAK WAS VISIBLE ANGIOGRAPHICALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 14084586 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS DESCRIPTION COVERS THE ARTICLE AS IDENTIFIED BELOW AS WELL AS THE TALK ON THE SAME SUBJECT. CITATIONS FOR BOTH ARE INDICATED BELOW. CITATION FOR THE TALK THAT OCCURRED 49TH ANNUAL SYMPOSIUM FOR THE SOCIETY OF VASCULAR SURGERY AT THE MIRAGE IN LAS VEGAS, NV MARCH 19-23, 2022: COLLAPSED ENDOGRAFT AND LOWER LIMB ISCHEMIA FROM TYPE B DISSECTION REPAIRED WITH TEVAR AND ILIAC STENTING PETER V. COOKE, BA1, HALBERT BAI, MPH1, JUSTIN M. GEORGE, MD2, CHRISTOPHER M. FARIES, BA1, AJIT RAO, MD2, MICHAEL L. MARIN, MD2, RAMI O. TADROS, MD2. 1ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI, NEW YORK, NY, USA, 2DIVISION OF VASCULAR SURGERY, MOUNT SINAI HOSPITAL, NEW YORK, NY, USA. CITATION FOR JOURNAL ARTICLE PRE-PROOF: P.V. COOKE, H. BAI, J.M. GEORGE, M.L. MARIN, R.O. TADROS, COLLAPSED ENDOGRAFT AND LOWER LIMB ISCHEMIA FROM TYPE B DISSECTION REPAIRED WITH TEVAR AND ILIAC STENTING: A CASE REPORT A REVIEW OF THE LITERATURE, JOURNAL OF VASCULAR SURGERY CASES AND INNOVATIVE TECHNIQUES (2022), DOI: HTTPS://DOI.ORG/10.1016/J.JVSCIT.2022.02.010. DEMOGRAPHICS: WE PRESENT THE CASE OF A (B)(6) MALE WITH A HISTORY OF RIGHT COMMON ILIAC ARTERY ANEURYSM WHO UNDERWENT EVAR WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS

  Patient problems: Ischemia

  MAUDE report 14042998 ↗
• MalfunctionOct 20, 2021Patient-Device Incompatibility; Material Deformation; Patient-Device Incompatibility; Material Deformation

  ON (B)(6) 2021, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT REPORTEDLY PRESENTED WITH AN AORTIC DIAMETER MEASURING 21 MM. ON (B)(6) 2021, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING REVEALED A COMPRESSION OF THE IPSILATERAL LEG OF THE IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS RLT261418. REPORTEDLY, THERE IS BLOODFLOW TOWARDS DISTAL AND THERE APPEARS TO BE NO THROMBUS. IT SEEMS THE IPSILATERAL LEG IS COMPRESSED AT THE LEVEL BETWEEN THE FLOW DIVIDER AND THE CONTRALATERAL LEG HOLE WHERE THE CONTRALATERAL LEG COMPONENT JOINS AS WELL AS DISTALLY. THE PHYSICIAN HAS TAKEN A WAIT - AND - WATCH APPROACH AS THE PATIENT IS REPORTEDLY ASYMPTOMATIC. THE FSA STATED THAT IMAGES WOULD BE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669441 ↗
• DeathMar 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON POST-OP FOLLOW-UP ON AN UNKNOWN DATE, AN UNCONFIRMED ENDOLEAK (SUSPECTED TO BE A PROXIMAL TYPE I) WAS OBSERVED. ON 8-MONTH POST-OP FOLLOW-UP ON AN UNKNOWN DATE, NO ENDOLEAK WAS PRESENT ON IMAGING. THE PHYSICIAN REPORTED THAT THE SUSPECTED ENDOLEAK WAS EXPECTED TO HAVE, "CLEARED UP". THE PATIENT WAS LOST TO FOLLOW-UP. ON (B)(6) 2021, THE PATIENT WAS IN A CAR ACCIDENT AND WAS FOUND TO BE DECEASED. UPON AUTOPSY IT WAS OBSERVED THAT THE PATIENT'S ABDOMINAL AORTIC ANEURYSM WAS RUPTURED. IT IS REPORTEDLY UNKNOWN IF THE RUPTURE WAS SECONDARY TO THE CAR ACCIDENT, OR IF THE CAR ACCIDENT WAS SECONDARY TO THE RUPTURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 11396378 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. ON (B)(6) 2021 AN ENDOLEAK WAS IDENTIFIED. ON THE SAME DAY, PERCUTANEOUS TRANSCAVAL COIL EMBOLIZATION OF THE ENDOLEAK WAS PERFORMED, ALONG WITH THE IMPLANT OF AN ADDITIONAL AORTIC ENDOGRAFT (MANUFACTURER UNKNOWN).

  Patient problems: Aneurysm

  MAUDE report 11338448 ↗
• MalfunctionDec 18, 2020Break; Difficult to Remove; Retraction Problem; Break; Difficult to Remove; Retraction Problem

  THE PATIENT WAS TREATED FOR AN ILIAC-ABDOMINAL ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. REPORTEDLY THE ANATOMY WAS NOT TORTUOUS. AFTER PERFORMING THE THREE DEPLOYMENT STAGES OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS THE DELIVERY CATHETER AND OLIVE TIP WAS UNABLE TO BE RETRACTED OUT OF THE PATIENT WITHOUT BRINGING THE 0.035" LUNDERQUIST GUIDE WIRE (TERUMO) WITH IT USED TO ADVANCE THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE DEVICE GOT STUCK ON THE LUNDERQUIST GUIDE WIRE. THEY CONFIRMED THAT THE OLIVE TIP DID NOT SEPARATE FROM THE DELIVERY CATHETER. IT WAS STATED THAT THE CASE WAS COMPLETED WITH NO PATIENT ISSUES. NO PATIENT INJURY RESULTED AT THE TIME OF THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11035758 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 55MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION DECREASED IN SIZE FROM 55 TO 42MM. IT WAS REPORTED THAT THE PATIENT DEVELOPED FATIGUE IN (B)(6) 2019 AND HAD A CT THAT SHOWED LOW ATTENUATION FLUID COLLECTION IN LEFT PSOAS. AN INDIUM-111 WBC SCAN COMPLETED ON (B)(6) 2019 CONFIRMED THE INFECTION OF THE AORTIC DEVICES AND THE ANEURYSM. ACCORDING TO THE PHYSICIAN, BACTEROIDES FRAGILIS WAS THE CAUSE OF INFECTION FROM PREVIOUSLY PERFORMED FLUID ASPIRATION. THE INFECTION COULD NOT BE DIRECTLY ATTRIBUTED TO THE GORE DEVICES, AS THE PATIENT HAD A LONG AND COMPLEX MEDICAL HISTORY THAT COULD HAVE ALSO ATTRIBUTED TO THE INFECTION. THE PATIENT SUFFERED FROM IRON DEFICIENCY ANEMIA WHICH COULD HAVE POSSIBLY ATTRIBUTED TO INFECTION. ALSO, THE INFECTION COULD NOT BE DIRECTLY ATTRIBUTED TO THE PROCEDURE PERFORMED ON (B)(6) 2016. REPORTEDLY, THERE WAS NO PRIOR HISTORY OF INFECTION. ON (B)(6) 2019, THE PATIENT UNDERWENT THE EXPLANT PROCEDURE AND ONIX COILS AND HAD A REPLACEMENT GRA

  Patient problems: Unspecified Infection

  MAUDE report 10855700 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND ANEURYSMS IN BOTH COMMON ILIAC ARTERIES THAT WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). ON (B)(6) 2019, A TYPE II ENDOLEAK WAS IDENTIFIED AND SUCCESSFULLY TREATED WITH POLYMER SAC FILLING. ON (B)(6) 2020, THE TYPE II ENDOLEAK WAS STATED TO BE PERSISTENT. THE ENDOLEAK WAS TREATED WITH EMBOLIZATION WITH LIQUID AGENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10633388 ↗
• InjuryJul 13, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020 THE PHYSICIAN PROVIDED FILMS FOR EVALUATION. THE DATE OF IMAGING WAS (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT HAD CLAUDICATION IN ONE LEG. INFORMATION REGARDING THE AMOUNT OF BLOOD FLOW THROUGH THE PATIENT'S LIMB AND IMPLANTED DEVICE WAS UNAVAILABLE. THE PHYSICIAN REPORTED THAT THE FILMS APPEARED TO SHOW A KINK IN THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG COMPONENT ALONG THE IPSILATERAL LIMB. THE IPSILATERAL LIMB WAS REPORTED TO BE LOCATED ON THE PATIENT'S RIGHT SIDE. IT WAS ALSO REPORTED THAT THE IPSILATERAL LIMB APPEARED TO BE ON THE INNER CURVE, AND DID NOT APPEAR TO HAVE RADIAL FORCE TO KEEP IT OPEN. IT WAS SUSPECTED THAT THE ISSUE WAS RELATED TO PATIENT ANATOMY AS IT REPORTEDLY APPEARED THAT THE DEVICE KINK MAY HAVE BEEN CAUSED BY AORTIC REMODELING AFTER THE INITIAL PROCEDURE. NO INTERVENTION HAS BEEN SCHEDULED. THE PATIENT WILL BE MONITORED.

  Patient problems: Claudication

  MAUDE report 10268530 ↗
• InjuryApr 1, 2020Partial Blockage; Patient-Device Incompatibility; Partial Blockage; Patient-Device Incompatibility

  ON (B)(6) 2018 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020 IMAGES WERE PROVIDED TO GORE. THE CT IMAGING DATE WAS (B)(6) 2020. IT WAS REPORTED THAT THERE APPEARED TO BE EITHER A TYPE III ENDOLEAK AT THE AORTIC JUNCTION, OR A TYPE II ENDOLEAK FROM THE LUMBAR ARTERIES. THROMBUS LAYERS ACROSS BOTH THE IPSILATERAL LEG AND CONTRALATERAL LEG COMPONENTS WAS ALSO REPORTED, WITH POSSIBLE OCCLUSION THROUGH BOTH LIMBS AT THE LEVEL OF DEVICE OVERLAP/LIMB CROSSING. EVALUATION OF THE IMAGES LATER REVEALED THAT THERE WAS NO EVIDENCE OF THROMBUS WITHIN THE LIMBS AT THE LEVEL OF THE CONTRALATERAL GATE. THE SUSPECTED CAUSE OF THE POSSIBLE TYPE III ENDOLEAK AND THROMBUS WAS REPORTEDLY UNKNOWN. REPORTEDLY IMAGING DEMONSTRATED SUFFICIENT (27MM) OVERLAP OF THE TRUNK-IPSILATERAL LEG COMPONENT AND THE CONTRALATERAL LEG COMPONENT, BUT CONTRAST WAS NOTED IN THE AREA OF THE DEVICE OVERLAP. ANEURYSM ENLARGEMENT WAS SUSPECTED (AMOUNT UNKNOWN). IT WAS REPORTED THAT NO PATIENT TORTUOSITY WAS NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. A REINTERVENTION WAS PERFORMED ON (B)(6) 2020. THE AMOUNT OF ANEURYSM ENLARGEMENT WAS R

  Patient problems: Aneurysm; Occlusion; Thrombus

  MAUDE report 9911392 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis
• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)